Post on 11-May-2021
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
Food and Drug Administration10903 New Hampshire AvenueDocument Control Center – WO66-G609Silver Spring, MD 20993-0002
Vascular Insight, LLCc/o Lorraine HanleyVice President, Regulatory Affairs1 Pine Hill DriveTwo Batterymarch ParkSuite 100Quincy, MA 02169
Re: K153502Trade/Device Name: ClariVein ICRegulation Number: 21 CFR 870.1210Regulation Name: Continuous Flush CatheterRegulatory Class: Class IIProduct Code: KRADated: December 1, 2015Received: December 7, 2015
Dear Ms. Hanley:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA’s issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act’s requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
January 6, 2016
Page 2 – Ms. Lorraine Hanley
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, Misbranding by reference to premarket notification (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH’s Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D.DirectorDivision of Cardiovascular DevicesOffice of Device EvaluationCenter for Devices and Radiological Health
Enclosure
for
Kenneth J. Cavanaugh -S
FORM FDA 3881 (8/14) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below.
510(k) Number (if known)K153502
Device NameClariVein IC
Indications for Use (Describe)The ClariVein IC is indicated for infusion of physician specified agents in the peripheral vasculature.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY (Page 1 of 3)
Device Name: ClariVein® IC Date Prepared: 6 January 2016
A. Submitter/Sponsor
Vascular Insights, LLC.
1 Pine Hill Drive,
Two Batterymarch Park
Suite 100
Quincy, MA 02169
Telephone Number/Fax: 617-519-1109/203-350-0311
Contact Person: Lorraine M. Hanley, Vice President Regulatory Affairs
B. Device Name Trade Name: ClariVein® IC
Common/Usual names: Intravascular Catheter, Infusion Catheter, Cannula
Classification Names: Continuous Flush Catheter
Regulation Number 21 CFR§870.1210
Classification: Class II
ProCode KRA
C. Predicate Device(s) ClariVein® IC
510(k) K071468
Common/Usual names: Intravascular Catheter, Infusion Catheter, Cannula
Classification Names: Continuous Flush Catheter
Regulation Number 21 CFR§870.1210
Classification: Class II
ProCode KRA
D. Device Description
The ClariVein IC is a specialty infusion catheter with 360˚rotatable fluid dispersion wire
connected to a proximally located integral battery powered motor drive unit (MDU). The
MDU includes the speed selector, handle grip and syringe support features which facilitate
physician-controlled infusion of the selected agent. The ClariVein IC is introduced through a
microintroducer. Utilizing vascular imaging, the coaxial catheter sheath with dispersion wire
is navigated through the vasculature to the treatment site. Fluid delivered through the
catheter assembly’s infusion port, surrounds the dispersion wire and exits via an opening at
the distal end of the catheter. The ClariVein IC has no user serviceable parts or capital
equipment. It is provided to the user sterile, for single patient use and is fully disposable.
510(k) SUMMARY (Page 2 of 3)
E. Indication For Use
The ClariVein® IC is indicated for infusion of physician specified agents in peripheral vasculature.
F. Technology Characteristics The ClariVein IC is a sterile, single use, low profile infusion catheter available in multiple lengths
and configurations for physician selection. Its distally located catheter assembly, including the
catheter shaft and a 360º rotatable dispersion wire, is connected to the proximally located motor drive
unit (MDU) powered by an integral, self-contained 9V battery and circuitry. Infusion is through an
opening at the distal end of the catheter and the fluid delivery is enhanced by use of a rotating
dispersion wire to deliver the infused fluid into the vessel and to the vessel wall. The rate of
rotation of the dispersion wire is physician determined and controlled via the MDU’s speed
selector. The device provides the user with four optional dispersion wire rotation speeds (RPM); i.e.
2,000 (Low), 2,500 (Medium), 3,000 (Medium-High) and 3,500 (High). Wire rotation is physician-
controlled by selecting the desired rotation speed and depressing the trigger. The ClariVein IC is
provided with labeling which presents instruction for the safe and effective use of the device.
The ClariVein IC is manufactured of materials demonstrated to be biocompatible for its intended use.
The ClariVein IC is not made with phthalate material or natural rubber latex. The ClariVein product
does not include medicants. There are no user serviceable parts or capital equipment. The device is
entirely disposable upon completion of the procedure.
G. Performance Data
The ClariVein IC has been assessed in accordance with relevant industry standards, FDA recognized
standards, and FDA Guidance documents. The product has been determined to meet all relevant parts
of the following industry standards and guidance documents:
ISO 10555-1 Singular Use Intravascular Catheter ISO 11607-1 Packaging
ISO 10993-1, -4, -5, -7, -10, -11 Biocompatibility ISTA 2A - Transportation
IEC 60601-1 3rd Ed. – Electrical Safety ISO 11135-1 - Sterilization
IEC 60601-2 – Electromagnetic Compatibility (EMC) ISO 15223-1, EN 1041, Labeling
ISO 11070 Sterile single use intravascular introducers,
dilators and guidewires
Summary of Nonclinical Tests
Nonclinical testing was performed on the ClariVein IC to support a determination of substantial
equivalence. The results of these tests provide reasonable assurance that the proposed device has been
designed and tested to assure conformance to the requirements for its intended use. No new safety or
performance issues were raised during testing. Testing included the follow:
Biocompatibility Hemocompatibility - Hemolysis
Direct/Indirect Contact
Hemocompatibility-Coagulation
Unactivated Partial Thromboplastin Time
Cytotoxicity
L929 Natural Red Uptake
Hemocompatibility
Thrombogenicity
Irritation/Sensitization
Kligman Maximization
Irritation/Sensitization
Intracutaneous Reactivity
Systemic Toxicity (acute)
Materials Mediated Rabbit Pyrogen
Systemic Toxicity - Acute Systemic Toxicity (acute)
Materials Mediated Rabbit Pyrogen
510(k) SUMMARY (Page 3 of 3)
Performance Testing Visual Quality
Test demonstrates that there are no
extraneous materials.
Corrosion
Test demonstrates that there are no
signs of corrosion.
Labeling Nominals
Test demonstrates that labeling
meets unit expressions.
Peak Tensile Tests:
Distal Tip to Sheath
Hub to sheath at strain relief
Hub to Guide Wing
Female coupling to male coupling
Male coupling to motor drive shaft
Wire to female coupling
Test demonstrates that all joints meet
requirements.
Dispersion Wire Tests:
Tensile
Fatigue
Test demonstrates that all joints
meet requirements.
Simulated Use
Test demonstrates functionality
in a simulated fixture.
Liquid leak under pressure
Test demonstrates no leakage
Wire rotation Speed
Test demonstrates required rotation
speed.
Torque Force to drive train
Test demonstrates torque
requirements.
Syringe and check valve functionality
Test demonstrates compatible functionality.
H. Clinical Testing
Not applicable.
I. Animal Testing
Not applicable.
J. Conclusion
Responses to questions posed in the FDA’s Substantial Equivalence Decision Flow Chart lead to a
determination of “substantial equivalence” for the subject ClariVein IC.
The ClariVein IC is substantially equivalent to the predicate in the following aspects:
Design, Function and Manufacture – the subject and predicate devices are substantially
equivalent to the technological characteristics of both designs. The predicate ClariVein IC is
available in 45 and 65 cm lengths; the proposed ClariVein IC introduces an 85 cm length
device.
Materials – There are no new materials used between the predicate and proposed devices.
Indications – Both the predicate and proposed devices have identical indications for use.
Packaging – The subject and predicate devices utilize similar packaging configurations
using industry accepted materials.
Sterilization – The subject and predicate devices are both sterilized utilizing a validated EO
sterilization process in accordance to ISO 11135.
Labeling – Both the subject and predicate device have similar labeling.
Testing was conducted to show that no new risks were identified and that the performance profile is
similar to the well-established predicate device cleared for market.